Trial Information
Oral Combination Chemotherapy in Conjunction With G-CSF in the Treatment of Elderly Patients With Intermediate and High Grade Non-Hodgkin's Lymphoma
OBJECTIVES:
- Assess the feasibility and toxicity of oral combination chemotherapy with granulocyte
colony-stimulating factor in elderly patients with intermediate and high grade
non-Hodgkin's lymphoma.
- Determine the objective response rate, response duration, and survival in this patient
population.
OUTLINE: All patients receive one cycle of oral chemotherapy, 6 weeks in duration. Etoposide
is given on days 1-3 and cyclophosphamide and procarbazine are given on days 22-31 of each
cycle. Lomustine is given on day 1 of cycles 1 and 3 only. Filgrastim (granulocyte
colony-stimulating factor; G-CSF) is given subcutaneously on days 5-21 and 33-42 of each
cycle.
Patients who have disease progression after one cycle of therapy or at any time thereafter
are taken off the study. Patients with a complete response after 1 cycle of therapy receive
2 additional cycles of chemotherapy and are observed off treatment. Patients with a partial
response (PR) also receive 2 additional cycles of chemotherapy. Following the third cycle of
chemotherapy, if residual disease is confined to 1 or 2 nodal sites, patients receive
radiation therapy. All other patients with a PR are treated at investigator's discretion.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Biopsy proven stage I through IV intermediate to high grade non-Hodgkin's lymphoma of
B-cell, T-cell, or indeterminate immunologic phenotype
- Measurable or evaluable
- No cytologic or radiographic evidence of CNS lymphoma
PATIENT CHARACTERISTICS:
Age:
- 60 and over
Performance status:
- ECOG 0-3
Life expectancy:
- At least 6 weeks
Hematopoietic:
- WBC at least 1500/mm3
- Platelet count at least 50,000/mm3
Hepatic:
- Bilirubin no greater than 3.0 mg/dL
Renal:
- Creatinine no greater than 3.0 mg/dL
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy allowed for localized stage I or II disease that has progressed
beyond initial radiotherapy ports
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
study the effectiveness of oral combination chemotherapy and G-CSF in elderly patients with intermediate- or high-grade non-Hodgkin's lymphomas.
Outcome Time Frame:
Patients receive one cycle of oral chemotherapy, 6 weeks in duration. Patients with a CR or PR response after 1 cycle of therapy receive 2 additional cycles of chemotherapy.
Safety Issue:
No
Principal Investigator
Scot C. Remick, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU4496
NCT ID:
NCT00003113
Start Date:
July 1997
Completion Date:
December 2002
Related Keywords:
- Lymphoma
- stage I grade 3 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult Burkitt lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- stage I mantle cell lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II mantle cell lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
Cleveland, Ohio 44106-5065 |
